180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

November 3, 2020 updated by: Temple University

A Randomized Trial of 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. Both protocols are now typically done by comprehensive ophthalmologists. However, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a prospective evaluation of the two treatment algorithms for SLT by measuring intraocular pressure (IOP) after treatment. The hypothesis is that 360 degrees of SLT will produce a greater reduction in IOP than 180 degrees of SLT at 3 months follow up.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19810
        • Brandywine Eye Center
    • Pennsylvania
      • Thorndale, Pennsylvania, United States, 19372
        • Levin Luminais Chronister Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
  • greater than 18 years of age
  • initial intraocular pressure (IOP) of ≥ 21 mmHg

Exclusion Criteria:

  • prior medical or laser therapy to lower IOP
  • previous incisional glaucoma surgery before the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 180 degrees
180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser
Procedure: Selective Laser Trabeculoplasty
The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.
Other Names:
  • SLT
Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser
The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.
Other Names:
  • Nd:YAG laser
Active Comparator: 360 degrees
360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser
Procedure: Selective Laser Trabeculoplasty
The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.
Other Names:
  • SLT
Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser
The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.
Other Names:
  • Nd:YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up
Time Frame: 3 months
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up
Time Frame: 1 year
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at 1 year of follow-up
1 year
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required
Time Frame: within 1 year of study intervention
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at time at which additional glaucoma therapy is required
within 1 year of study intervention
Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up
Time Frame: within 1 year of study intervention
Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at last follow-up
within 1 year of study intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry
Time Frame: within 1 year of study intervention
If IOP spike occurs, it will be treated accordingly.
within 1 year of study intervention
Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy
Time Frame: within 1 year of study intervention
If trabeculitis occurs, it will be treated accordingly.
within 1 year of study intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Investigators

  • Principal Investigator: Jeffrey D. Henderer, MD, Temple University
  • Study Director: Sophia Siu, MD, Temple University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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